BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23360706 · Received October 22, 2025

    Report

    Report Number
    2955842-2025-42277
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    July 10, 2025
    Report Date
    September 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114308
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE NEEDLE DRIVER INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT MOVEMENTS DID NOT CORRESPOND TO THE CONSOLE SURGEON. THERE WAS NON-INTUITIVE MOTION. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611698 ENDOWRIST SP NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 430006-62 K10241121 0003 00886874114308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES